Senior Director, Clinical Development
1 week ago
The Senior Director of Clinical Development will provide direction and technical leadership in the development and execution of clinical development plans for drug candidates and contribute to the Clinical Development strategy. The ideal candidate will have a track record of designing and executing robust clinical studies, leadership in providing expert input in scientific discussions and proactive engagement in interactions with thought leaders, health authorities, regulatory bodies and experience working with CROs. In this role, the ideal candidate's guidance and learning throughout the planning and implementation phases will ensure clinical development timelines are met across the organization. The Senior Director of Clinical Development will report to the Chief Medical Officer (CMO).
How You'll Contribute
- Design and direct Phase 0-3 clinical trials for radioligand therapy compounds.
- Author and/or collaborate with clinical and other teams to create documents such as Study Concepts/Synopses, Protocols, ICFs, Investigator Brochures, INDs, NDAs, Briefing Documents, abstracts, manuscripts and provide medical and scientific input into the development of deliverables required for study activation, conduct, and closure (CRFs, SAP, Data Listings, CSRs, etc.)
- Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization.
- Ensure clinical trials are conducted according to good clinical practice and all applicable regulatory requirements, standard operating procedures, and other quality standards.
- Responsible for collaborating and driving implementation of the clinical program through cross-functional teams; completing studies on time and within budget.
- Contribute to and optimize an effective KOL and investigator communication strategy. Interact with investigators as warranted to obtain necessary information before, during and after the study.
- Organize and present at KOL advisory board and investigator meetings.
- Provide medical review, analysis and medical guidance during the case handling and reporting process for Adverse Event and Adverse Reaction reports received for the Company's investigational products.
- Plan, oversee and direct risk management activities for investigational compounds.
- Respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans.
- Monitor and keep current on industry best practices, pharmacovigilance and changes in global safety regulations and guidelines.
- Train/mentor colleagues, CRO and study site staff on the therapeutic area, molecule, and clinical documents as appropriate.
- Working with other departments, create functional policies and procedures to provide strong and efficient clinical development processes that are appropriate for a matrixed environment.
- Support product lifecycle management for new indications as requested.
- MD, DO, or equivalent ex-US medical degree with 5+ years of clinical development experience, including at least 3 years in the pharmaceutical/biotech industry or as a clinical trial investigator, with experience managing radiopharmaceutical clinical trial programs.
- Expertise in nuclear medicine and/or oncology highly desired.
- Comprehensive understanding of clinical research regulations, including GCP, ICH guidelines, and other US and international requirements.
- Superior planning and project management skills, including risk assessment and contingency planning, with the ability to manage multiple projects simultaneously.
- Strong scientific acumen, analytical abilities, and sound clinical judgment, demonstrating credibility and integrity consistent with the company's values.
- Effective communicator with the ability to present ideas and document complex medical/clinical concepts clearly in both written and oral form.
- Decisive and collaborative leader, capable of working independently and as a respected team member.
- Comfortable working in a small, resource-constrained start-up environment.
- Ability to travel as required (up to 25%).
What's in it for you
At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
Pay Transparency Statement
Alpha-9 Oncology is committed to pay transparency and equitable compensation practices. Compensation for this position will align with the defined scope and responsibilities of the role and will take into account factors such as education, experience, and internal equity.
In addition to base salary, this role is eligible for an annual performance bonus, participation in our equity incentive plan, and a comprehensive benefits package.
Per Year Salary Range
$308,000-$390,000 USD
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More about Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
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